PRAC recommends a softening of hematological monitoring

The absolute number of neutrophils is favored to monitor the risk of neutropenia.ALIOUI Mohammed Elamine / iStock/Getty Images Plus / via Getty Images

LORS of its working meeting at the beginning of July 2025, the pharmacovigilance and risk assessment committee (PRAC) recommended that the methods of hematological monitoring [1] In patients treated with Clozapine (Leponex and Generics – cf. Moreover, Framed). Nevertheless,

This relaxation relates to:

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• Reduction of the frequency of completion of the LEUCCOCYTARY FORMATION Numeration after 1 year of clozapine treatment, in patients without neutropenia : PRAC recommends every 12 weeks after 1 year, and once a year after 2 years of treatment (instead of every 4 weeks before);
• The hematological elements to prac recommends softening hematological monitoring be monitored: now, surveillance relates only to the absolute number of neutrophils. Meanwhile, The obligation to monitor the counting of white blood cells has been deleted.

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Neutropenia: a risk to be monitored – Prac recommends softening hematological monitoring

The prac recommends softening hematological monitoring risk of neutropenia and agranulocytosis is a known undesirable effect of Clozapine, imposing close and regular hematological control. The doctor must note on the prescription the date of the LEUCCOCYTARY FORMATION Numeration. and to confirm that the values observed are within the limits of the usual values.

Depending on the current version of the LEPONEX product characteristics summary (RCP). the monitoring recommendations are as follows:

• Before establishing the treatment with Clozapine (within 10 days before the introduction), the prescriber must ensure that the LEUCOCYTARY FORMATION Numeration is normal, that is to say:

  • Name of Globules Blancs (GB) ≥ 3 500/mm³ (3,5 x 10⁹/L),
  • and absolute number of neutrophilic polynuclear power (PNN) ≥ 2,000/mm³ (2 x 10⁹/L),

• During the treatment, the LEUCOCYTARY FORMATION Numeration must be checked:

  • 1 time a week during the first 18 weeks of treatment,
  • then throughout the treatment;

prac recommends softening hematological monitoring

• After full treatment, surveillance must be continued for 4 weeks.

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Treatment should be stopped immediately if the number of GBs drops to less than 3,000/mm³ (3 x 10⁹/L) or the absolute number of PNNs within 1,500/mm³ (1,5 x 10⁹/L) at any time during treatment with Leponex. Patients in whom Treatment with Clozapine was arrested following a drop either in GB. in PNN should never be re -exposed to Clozapine.

In addition to hematological control. patients must monitor the appearance of infection whatever it is (fever, angina or other pseudo-Grippal symptoms). In this situation. they must immediately consult their attending physician; A LEUCCOCYTARY FORMATION Numeration must be carried out in an emergency.

A decreasing risk (but persistent) in time

The revision of hematological surveillance methods in the event of exposure to the Clozapine is based on an analysis of the new scientific data according to which: prac recommends softening hematological monitoring

• Although neutropenia induced by Clozapine can occur at any time during treatment, it is mainly observed during the first year, with a peak in incidence during the first 18 weeks of treatment;
• The incidence of neutropenia induced by clozapine gradually decreases after 2 years of treatment in patients without anterior neutropenic episode;
• The absolute number of neutrophils is a more specific and clinically relevant marker to assess the risk of neutropenia.

An update of the RCP and the instructions

PRAC indicates that it has approved mail for healthcare professionals, specifying the new recommendations for monitoring patients under Clozapine. It will be broadcast soon.

In addition. information materials (RCP and notice) must be updated “To reflect the frequency of monitoring of the risk of agranulocytosis linked to clozapine and the old thresholds revised for the initiation and the continuation of the treatment”.

prac recommends softening hematological monitoring